Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090719
Company: NOVAST LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVONEST ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG TABLET;ORAL-28 Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/29/2010 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2017 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

LEVONEST

TABLET;ORAL-28; 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ELIFEMME ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG TABLET;ORAL-28 Prescription No AB 202507 LABS LEON FARMA
ENPRESSE-28 ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG TABLET;ORAL-28 Prescription No AB 075809 DURAMED PHARMS BARR
LEVONEST ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG TABLET;ORAL-28 Prescription No AB 090719 NOVAST LABS LTD
LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG TABLET;ORAL-28 Prescription No AB 200248 LUPIN LTD
MYZILRA ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG TABLET;ORAL-28 Prescription No AB 077502 VINTAGE PHARMS LLC
TRIVORA-28 ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG TABLET;ORAL-28 Prescription No AB 074538 MAYNE PHARMA

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English